Kornimate/medical-research-clean huggingface dataset:
axios stent with electrocautery enhanced delivery system

Conditions: Pancreatic Pseudocyst(s)

Summary: the purpose of this study is to demonstrate the safety and effectiveness of the axios stent with electrocautery enhanced delivery system for endoscopic transenteric drainage of pancreatic pseudocysts.


Eligibility criteria:
inclusion criteria: 1. age between 18 and 75 years old, male or female 2. eligible for endoscopic intervention 3. acceptable candidate for endoscopic transluminal pancreatic pseudocyst drainage 4. symptomatic pancreatic pseudocyst having the following characteristics: * greater or equal to 6 cm in diameter (based upon the maximum cross-sectional area in the ct scan or transabdominal ultrasound). * adherent to bowel wall, and * ≥70% fluid content 5. patient understands the study requirements and the treatment procedures and provides written informed consent. 6. patient is willing to comply with all specified follow-up evaluations, including willingness to undergo a pre/post ct imaging study. exclusion criteria: 1. the fluid collection to be drained is an immature pseudocyst 2. the fluid collection to be drained is a cystic neoplasm 3. the fluid collection to be drained is a pseudoaneurysm 4. the fluid collection to be drained is a duplication cyst 5. the fluid collection to be drained is a non-inflammatory fluid collection 6. there is more than one pseudocyst requiring drainage 7. abnormal coagulation: * inr \> 1.5 and not correctable * presence of a bleeding disorder * platelets \< 50,000/mm3 8. altered anatomy that precludes the physician's ability to deliver the stent (decision on a case by case basis). 9. intervening gastric varices or vessels within a one centimeter radius of the needle (visible using endoscopy or endoscopic ultrasound) 10. any prior true anaphylactic reaction to contrast agents, nitinol (nickel titanium), silicone or any other materials contacting the patient. 11. female of childbearing potential with a positive pregnancy test prior to the procedure or intends to become pregnant during the study. 12. currently participating in another investigational drug of device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study.

Keywords: pancreatic pseudocyst
letrozole versus chinese herbal medicine on polycystic ovary syndrome (pcos)

Conditions: Polycystic Ovary Syndrome

Summary: this is a multicenter double-blind randomized controlled trial. a total of 420 anovulatory chinese women with pcos will be recruited, and the randomization will be stratified by each participating site. participants will be randomized into one of the two treatment arms: letrozole and chmg or letrozole and chmg placebo. chmg or its placebo will be taken twice a day for up to six months. letrozole (2.5 mg daily) was given on days 3-7 of the menstrual cycle after a spontaneous period or withdrawal bleeding, and the dose will be increased to 5.0 mg daily during the last three months for non-pregnant women in both groups.the aim of the present study is to determine the efficacy of combined treatment with letrozole and chmg on improving live birth rates in infertile chinese women with pcos. our hypothesis is that the combination of letrozole and chmg is more likely to increase the ovulation rate and decrease the miscarriage rate and result in a higher live birth rate in pcos women than letrozole alone.


Eligibility criteria:
inclusion criteria 1. chinese women with pcos. pcos must have been diagnosed based on the presence of two of the following three rotterdam criteria : (1) oligomenorrhea, anovulation; (2) hyperandrogenism; and (3) the observation of polycystic ovaries by sonography. oligomenorrhea is defined as an intermenstrual interval \>35 days or \ 90 days. 2. history of at least one year of infertility. 3. age between 20 and 40 years old. 4. normal semen analysis based on world health organization criteria (2010). the husband did not need to sign the consent form because semen analysis is part of the clinical assessment at the sites. a sperm concentration ≥15 × 106/ml and total motility ≥40% in the semen analysis of the husband was required for the woman to be included. 5. normal uterine cavity and at least one tube patent upon hysterosalpingography or hycosy. exclusion criteria 1. history of significant system diseases such as heart, lung, or kidney diseases. 2. history of other endocrine disorders. 3. use of hormonal therapy, including metformin, in the past 3 months. 4. previous sterilization procedures (vasectomy or tubal ligation) that have been reversed.

Keywords: polycystic ovary syndrome randomized controlled trial chinese herbal medicine chinese herbal medicine granules letrozole live birth
study of unilateral neck irradiation in patients with scc of the head and neck

Conditions: Squamous Cell Carcinoma of the Head and Neck

Summary: the purpose of this study is to assess the feasibility of avoiding opposite side neck radiation therapy in patients with clearly one side squamous cell cancer of the head and neck. we aim to assess the reduction in treatment volume (amount of radiation therapy required), and the resultant xerostomia and mucositis, with the delivery of unilateral neck radiation therapy.

patients will be treated with definitive external beam radiation plus/minus chemotherapy plus/minus neck dissection in the ipsilateral neck (post radiation). the primary site will be treated with definitive radiation therapy, or definitive surgery plus post-operative radiation therapy. primary endpoints are loco-regional control, as well as quality of life, xerostomia, mucositis, and neck fibrosis. salivary evaluations shall be performed prior to the initiation of radiation therapy, during the second week of ebrt, and at the completion of radiation. evaluations will also be conducted at 3, 6, and 12 months after the completion of ebrt. oral mucositis will be assessed prior to the initiation of ebrt and weekly during ebrt. evaluations will also be conducted at 3 and 6 months after the completion of ebrt. two standardized mucositis scales will be used: the rtog scale and the who scale. clinical response will be evaluated by physical exam and pet/ct. pet/ct scans will be done at 3, 6, 12, 18, and 24 months, and then when clinically indicated during follow-up.

Eligibility criteria:
inclusion criteria: * squamous cell carcinoma of the oral cavity or oropharynx, with the primary lesion \>1 cm from the midline. * patient has no clinical or radiologic evidence of contralateral neck node metastases. * no evidence of distant metastasis. * no previous history of radiation therapy or chemotherapy * performance status 0-2 * age \>= 18 * signed informed consent * patients must be accessible for treatment and follow-up exclusion criteria: * hiv positive patients * pregnancy or any patients not practicing contraception * active tobacco or alcohol addiction (as assessed by medical caregiver) * serious comorbid disease which prevents delivery of full treatment including psychiatric disorders, cardiopulmonary disease, etc. * concomitant use of any trial anticancer therapeutic within 30 days of entry * uncontrolled hypertension * known hypersensitivity to mammalian cell-derived products
selective neck dissection versus modified neck dissection in ptc

Conditions: Thyroid Cancer

Summary: this study is a phase iii, randomized controlled, open label non inferiority study. patients who meet the inclusion criteria are randomly assigned 1:1 to either the experimental group (selective neck dissection) or the control group (modified neck dissection), with lrfs as the primary endpoint. the aim of the study is to evaluate the safety of selective neck dissection in papillary carcinoma with limited number of lymph node metastases in the lateral neck, and the quality of life compared with modified neck dissection.


Eligibility criteria:
inclusion criteria: * pathologically confirmed ptc; * age range: 14-80 years old; * preoperative fine needle aspiration confirms lymph node metastasis in the lateral neck * ultrasound and ct suggest that metastatic/suspected metastatic lymph nodes are limited to compartment iv, with 1-2 lymph node metastases and \<1cm in short diameter. the lymph nodes have no central necrosis, liquefaction, peripheral enhancement, or disappearance of adjacent fat spaces (predicting unobstructed lymphatic vessels); * thyroid tumors without extra thyroidal extension; * enough thyroid volume to inject tracer. exclusion criteria: * previous neck surgery; * bilateral neck lymph node dissection; * distant metastases; * high risk pathological subtypes or the presence of other high-risk factors for recurrence; * previous treatment for thyroid cancer other than endocrine therapy; * the patient is unable to cooperate with follow-up.
clinical risk scores in prediction outcome of acute ugit bleeding in non cirrhotic patients

Conditions: Upper GI Bleeding

Summary: to compare the ability of 4 bleeding risk scoring systems (glasgow -blatchford score, map, h3b2 and abc scores ) in prediction of: need of intervention, re bleeding, thirty-day mortality, length of hospital stay

acute upper gastrointestinal bleeding (ugib) is a common medical emergency which has a variceal and non-variceal etiology. the non variceal etiology has higher incidence in many countries. in egypt, non-variceal causes ranged from 26.1% to 61.6% among ugib cases presented to the emergency departments of different university hospitals. guidelines recommend risk stratification early in the management of patients with acute ugib to help triage patients into the appropriate level of care. many scoring systems for ugib were developed and validated from 1990s onwards. their primary aim was to segregate the patients into low-risk and high-risk groups. high risk patients with ugib includes those who reach some or all of the endpoints: requirement of blood transfusion, endo-therapeutic, surgical or radiological intervention to achieve hemostasis, re bleeding and mortality. unfortunately, no single risk score has been shown to be accurate at measuring all relevant outcomes. the most widely used score is glasgow blatchford "gbs" which is a pre endoscopic score. it is useful in prediction of therapeutic intervention for bleeding. more recently, other scores have been developed as abc score which showed good performance for predicting mortality. map score highly predicted therapeutic intervention and mortality. h3b2 score predicted the need of urgent hemostasis. limited data are available on the validity of the new scoring systems in predicting the outcome of egyptian non-cirrhotic patients with acute ugib. therefore, the investigators will conduct our study to shed some light on this topic.

Eligibility criteria:
inclusion criteria: * adult non cirrhotic patients * patients more than 18 years old * hematemesis or coffee grounds vomiting. * melena with or without hematemesis. * blood in nasogastric tube in emergency unit. exclusion criteria: * patients younger than 18 years old. * patients known to be cirrhotic. * patients presented with git bleeding but refuse to be examined by git endoscopy.
effective dose of statin post pci

Conditions: Statin Dose

Summary: in this study post coronary stenting patients, were enrolled to receive moderate dose versus high dose statin for 1 year, and the result of major adverse cardiovascular events were recorded

in this randomized double-blind clinical trial, the study population was all patients with a recent history of pci who referred to the professor kojuri cardiovascular clinic for the first post-procedure visit. in the first visit, patients were randomly divided into two groups both groups were treated with rosuvastatin 40 mg as high potency statin for one month after pci. in the first group, after one month, the statin level changed to rosuvastatin 5 mg daily (moderate intensity). in the second group, 40 mg of rosuvastatin was continued for one year. then, the participants were evaluated in terms of maces, including any hospitalization due to acute coronary syndrome, as well as history of stroke and myocardial infarction, subsequent unplanned revascularization and cardiac death. the hs-crp also checked between two groups

Eligibility criteria:
inclusion criteria: * all patients who have undergone pci due to chronic stable angina exclusion criteria: * patients with acute coronary syndrome * primary ldl\>190 mg/dl * patients who developed statin-induced myopathy or rhabdomyolysis * persistent increase in hepatic enzyme levels or hepatic failure * pregnancy and breast feeding * statin hypersensitivity * patients with history of multiple atherosclerotic events * patients who received high intensity statin before the study enrollment.

Keywords: pci stable angina statin therapy
tns for treating nicotine craving

Conditions: Nicotine Craving

Summary: electrical stimulation provides direct modulatory effects on subcortical regions. indeed, neuroimaging studies show changes in neural activity in specific brain regions such as the amygdala, insula, precentral gyrus, hippocampus and thalamus. the neuroanatomical connections established with the trigeminal nerve have been associated with the mechanism called "bottom-up" neuromodulation. according to this hypothesis, the spread of electrical stimulation follows a path from the peripheral nerves towards the brain stem was then advertise for cortical and subcortical regions. connections to structures involved in the reward system as the amygdala and hippocampus could theoretically modulate dysfunctional brain activity in these regions, which may induce favorable clinical effects.


Eligibility criteria:
inclusion criteria: 1. patients over 18 years 2. both genres 3. diagnosed with nicotine related disorder for at least 12 months according to the diagnostic criteria of dsm-iv administered by a psychiatrist. 4. also we will adopt as inclusion criteria a score of nicotine dependence fagerstrom test greater or equal to 5 points. 5. finally, patients should be able to read and understand the portuguese language. 6. patients will be selected from spontaneous demand. in accordance to informed consent - exclusion criteria: 1. other psychiatric diagnosis such as bipolar affective disorder, alcohol dependence, schizophrenia and dementia. 2. also excluded patients with severe neurological or medical diseases, such as neurodegenerative diseases, stroke, cancer in activity, congestive heart failure or chronic obstructive pulmonary disease stage iii or iv. 3. finally, patients with severe suicidal ideation (structured planning suicide or attempted suicide in the past 4 weeks) will be excluded. in this case, the patient will be seen immediately by a psychiatrist of the research itself that will take the appropriate clinical management according to the severity of suicidal thinking. -
muscle damage and disuse atrophy

Conditions: Muscle Disuse Atrophy

Summary: limb injury generally requires a period of recovery during which time the limb is often immobilised (e.g. with a cast or brace) resulting in a rapid loss of skeletal muscle. despite the importance of muscle loss during injury, our understanding of how it occurs is incomplete. several factors are likely to contribute, including a lack of muscle contraction and injury induced inflammation. in this study, the investigators will recruit healthy volunteers who will spend 7 days in a knee brace to replicate leg immobilisation. prior to immobilisation, half of the participants will perform a single session of strenuous resistance exercise which is known to cause muscle damage and initiate an inflammatory response. this is designed to replicate the muscle damage and inflammation that occurs with injury. the remaining half of participants will not perform this exercise, allowing us to look at the additive effect of muscle damage and inflammation on muscle loss with immobilisation.


Eligibility criteria:
inclusion criteria: * aged 18 - 40 * bmi between 18 and 27 * healthy, recreationally active, non smoker exclusion criteria: * non-removable metallic implants (including heart pacemaker, cochlear implants, medication pumps, surgical clips, plates or screws) or claustrophobia * use of nutritional supplements * chronic use of over the counter medication * any diagnosed metabolic disease (e.g. type 1 or 2 diabetes). * any diagnosed cardiovascular disease or hypertension. * anyone with previous motor disorders. anyone with a current musculoskeletal injury that may impair their use of crutches.

Keywords: muscle damage inflammation immobilisation
clinical evaluation of a multifocal contact lens on symptomatic patients

Conditions: Presbyopia

Summary: the purpose of this study is to evaluate the effect of a multi-focal contact lens on symptomatic patients.


Eligibility criteria:
inclusion criteria: * to have signed an informed consent form (documented by the investigator in the case report form \[crf\]). * be existing daily wear spherical single-vision soft cl wearers (no extended wear in the last 3 months, but silicone hydrogels in daily wear are allowed). * between 35 and 47 years of age (inclusive). * have a cl spherical distance requirement between -1.00d and -6.00d (-6.50d refractive) in both eyes. * refractive astigmatism of 0.75d or less in both eyes. * visual symptoms associated with near vision * be correctable to a visual acuity of 6/9 (20/30) or better in each eye. * have normal eyes with no evidence of abnormality or disease. for the purpose of this study a normal eye is defined as one having: 1. no amblyopia. 2. no evidence of lid abnormality or infection. 3. no conjunctival abnormality or infection. 4. no clinically significant slit lamp findings (i.e. stromal haze, staining, scarring, vascularization, infiltrates or abnormal opacities). 5. no other active ocular disease. exclusion criteria: * monovision user or multifocal cl wearer. * regular user of reading spectacles (i.e. daily usage). * requires concurrent ocular medication. * clinically significant (grade 3 or 4) corneal stromal haze, corneal vascularization, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any other abnormality of the cornea that would contraindicate cl wear. * corneal staining grade 3 in more than two regions. * has had any anterior ocular surgery. has had any other ocular surgery or injury within 8 weeks immediately prior to enrollment for this study. * pre-existing ocular irritation that would preclude cl fitting. * keratoconus or other corneal irregularity.
bioequivalence of two formulations of biphasic insulin aspart 50 in healthy male subjects

Conditions: Diabetes; Healthy

Summary: this trial is conducted in africa. the aim of this trial is to investigate the bioequivalence of two formulations of biphasic insulin aspart 50 in healthy male subjects.


Eligibility criteria:
inclusion criteria: * considered generally healthy upon completion of medical history and physical examination, as judged by the investigator * body mass index (bmi) between 19-29 kg/m\^2 (both inclusive) * minimum body weight of 65 kg * fasting blood glucose between 3.8-6.0 mmol/l * glycohemoglobin (hba1c) below 6.4 % * non-smokers exclusion criteria: * clinically significant abnormal hematology, biochemistry, urinalysis or ecg (electrocardiogram) screening tests, as judged by the investigator * a history of any illness that, in the opinion of the investigator and/or sponsor, might confound the results of the study or pose additional risk in administering the investigational product to the subject * history of or current addiction to alcohol or drugs of abuse as determined by the investigator (positive drug/alcohol abuse screen) * hepatitis b or c * subjects with a first-degree relative with diabetes mellitus * known or suspected allergy to trial product or related products * smoking during the past three months
cd147 targeting nanobody probe for pet imaging in solid tumors

Conditions: Solid Tumor

Summary: the objective of the study is to construct a noninvasive approach using 68ga-nota-mal-nb147 pet/ct to detect the cd147 expression of tumor lesions in patients with solid tumors and to identify patients benefiting from cd147 targeting treatment.


Eligibility criteria:
inclusion criteria: 1. histopathologically or cytologically confirmed malignant melanoma, hepatocellular carcinoma, colorectal cancer, pancreatic cancer, breast cancer, gastric cancer, and lung cancer. 2. aged ≥18 and ≤75 years, with no gender restrictions. 3. ecog score of 0 or 1. 4. expected survival time ≥6 months. 5. at least one easily accessible lesion that can be biopsied within one month before or after the pet scan. the patient consents to using archived or fresh biopsy tissue samples for relevant analysis. 6. blood routine and liver/kidney function must meet the following criteria: blood routine: wbc ≥ 4.0×10⁹/l or neutrophils ≥ 1.5×10⁹/l, plt ≥ 100×10⁹/l, hb ≥ 90 g/l; pt or aptt ≤ 1.5 uln; liver/kidney function: t-bil ≤ 1.5×uln (upper limit of normal), alt/ast ≤ 2.5×uln or 5×uln (for subjects with liver metastases), alp ≤ 2.5×uln (if bone or liver metastases exist, alp ≤ 4.5×uln); bun ≤ 1.5×uln; scr ≤ 1.5×uln; at least one measurable target lesion according to recist 1.1 criteria. 7. women must use contraceptive measures during the study or for six months after the study ends (effective contraceptive methods include sterilization, hormonal intrauterine devices, condoms, contraceptive pills/devices, abstinence, or partner tubal ligation, etc.). men must agree to use contraceptive measures during the study or for six months after the study ends. 8. able to understand and voluntarily sign the informed consent form, with good compliance. exclusion criteria: 1. pregnant or breastfeeding women, or women planning to become pregnant during the study or within three months after administration, as well as individuals donating sperm or oocytes. 2. individuals known or suspected to be allergic to the investigational drug or any of its components. 3. individuals with significantly abnormal liver or kidney function: serum total bilirubin (tbil) \> 1.5 × 20 µmol/l, or aspartate aminotransferase (ast) \> 2.5 × 45 µmol/l, or alanine aminotransferase (alt) \> 2.5 × 40 µmol/l, or serum creatinine \> 1.5 × 130 µmol/l. 4. unable to cooperate in completing the pet scan, or suffering from claustrophobia or other conditions that prevent cooperation during the pet scan. 5. other situations deemed inappropriate for participation in the trial by the investigator. female patients who are pregnant or breastfeeding.

Keywords: cd147 solid tumor